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Drug research, development and expenditure - what about the future?

Drug research and development today is an undertaking requiring special skills and understanding, formidable financial resources and the closely co-ordinated co-operation of everyone concerned with the drug programme in all its aspects. Incorrect results, wrong deductions or decisions and unrealistic delays due to bureaucratic obstructions, all have an adverse effect in the final analysis. The price (financially and otherwise) we have to pay for the end-product is invariably intimately related to what happened during the entire development process. Everyone connected with drug development, in whatever capacity, has a moral obligation to ensure that the development programme follows a path which is as smooth as possible.

Forecasting

The role of the individual and the community in the research, development, and use of biologicals with criteria for guidelines: a memorandum.

In view of the widely recognized need to use available vaccines and other biologicals and to develop new ones to control many diseases of world-wide importance, this Memorandum considers the increasingly complex problems that face investigators and public authorities that must review and approve pre-licensing studies and also large-scale regular use. It is stressed that the proper conduct of biologicals research in human beings must be considered from the scientific, sociological, ethical, and legal points of view. The Declaration of Helsinki is regarded of fundamental importance and its applicability to biologicals research is discussed. Recommendations are made for continued international collaboration in this field and "Criteria on the Role of the Individual and the Community in the Research, Development, and Use of Biologicals" are formulated. General criteria and specific criteria related to the design of field trials, human involvement in field trials, and surveillance of safety and effectiveness of biologicals in routine use are discussed.

Biological Products